Associate Director, Regulatory Affairs - CMC

Lead global regulatory CMC strategy for small molecule product development and registration, including preparation of CMC submissions (INDs, NDAs, MAAs, NDS, eCTDs) and lifecycle management for manufacturing changes, technology transfer, and post-approval activities. Partner with Regulatory Affairs, Technical Operations, and Quality to ensure timely, compliant documentation and successful regulatory outcomes. Develop robust global strategies, manage agency interactions, and drive high-quality submissions (eCTDs, briefing documents, responses to queries). Requires strong ability to interpret regulatory guidance, coordinate cross-functional teams, and support a fast-paced regulatory program. Travel up to 10% and a Bachelor’s degree in a scientific field with 7-8 years of Regulatory Affairs/CMC experience; advanced degree a plus.